Code of practice - Requirements for installation, testing and commissioning and acceptance of medical device
This Malaysian Standard applies to medical devices placed for use in any healthcare facility or any other facility or residential premises which require installation, testing and commissioning (T&C) and acceptance, excluding implantable medical devices. This standard is intended to:
a) Provide guidance to comply with the requirements under Section 43, Usage, operation and maintenance of medical device in the Medical Device Act 2012 (Act 737);
b) Provide guidance on the procedures for the installation, T&C and acceptance of medical devices in any healthcare facility, aesthetic settings, and premises for wellness programmes and related services; and
c) Ensure the medical device is appropriately installed, tested and commissioned by the equipment specialists or competent personnel and accepted in accordance with the manufacturer’s specification, purchase agreement and statutory requirement
Published
PDF
28/09/2021
45
NSC 18 - Medical Devices and Facilities for Healthcare
